505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors

Sponsors can use the 505(b)(2) pathway to develop drugs with new indications, dosage forms or strengths, formulations, dosing regimens, routes of administration, or even active ingredients. In many cases, these changes create new, differentiated products that patients or healthcare providers prefer over previous versions, leading to both improved experiences for patients and tremendous commercial value for sponsors.

Register for this webinar to discover early planning best practices for building and executing a successful, streamlined 505(b)(2) development program and to hear a case study demonstrating how a product developed through this pathway can dramatically improve the patient journey.

Topics in this presentation include:

  • What is the 505(b)(2) regulatory pathway?
  • What are the benefits and regulatory implications of the 505(b)(2) pathway?
  • How can a sponsor prepare and plan for a 505(b)(2) development program?
  • How can the 505(b)(2) pathway be leveraged to improve the patient journey?

Cathy Gatza, PhD, VP of Regulatory and Strategy, Camargo, and
Andrea Miller, Manager of Life Science Solutions, Camargo